Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-25 @ 4:50 PM
Study NCT ID:
NCT01117103
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2010-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Observational Study to Assess and Evaluate the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3592}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-15', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who discontinue Glucophage XR treatment prematurely (< 12 weeks) due to side effects', 'timeFrame': 'Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects experiencing at least one gastrointestinal side effect', 'timeFrame': 'Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier'}, {'measure': 'Proportion of subjects remaining on Glucophage XR therapy for at least 12 weeks', 'timeFrame': 'Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)'}, {'measure': 'Incidence of side effects', 'timeFrame': 'Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier'}, {'measure': 'Reasons for discontinuation', 'timeFrame': 'At the time of discontinuation before completing the 12 weeks observation of period'}, {'measure': 'Change in glycosylated haemoglobin (HbA1c) levels from baseline after 12 weeks', 'timeFrame': 'Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Diabetes Mellitus', 'Glucophage', 'Metformin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This was an observational, prospective, multicentric study conducted in a cohort of subjects with type 2 diabetes and prescribed with Glucophage XR therapy from hospitals or clinics in Hong Kong, Indonesia, Korea, Malaysia, Philippines and Singapore. Glucophage XR is being used in the Asia Pacific region for the treatment of subjects with type 2 diabetes. This study was designed to provide information on the day to-day experience of using Glucophage XR in the management of subjects with type 2 diabetes and its use in routine clinical practice in Asia Pacific region.', 'detailedDescription': "Glucophage (metformin) is the standard first line therapy for subjects with type 2 diabetes mellitus (DM). The consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes has recommended metformin therapy in concurrent with lifestyle intervention at diagnosis. It has been well accepted that subjects' compliance with therapy tends to decrease as the dosage frequency increases and hence the regimens should be simplified as far as possible to support good compliance with therapy. The use of an extended release formulation of metformin (Glucophage XR) supports the simplification of treatment of subjects with type 2 diabetes by allowing a once daily administration of metformin.\n\nOBJECTIVES\n\nPrimary objective:\n\n* To assess the tolerability of Glucophage XR therapy when used in routine clinical practice in subjects with type 2 diabetes\n\nSecondary objective:\n\n* To assess the effectiveness of Glucophage XR therapy on the maintenance of glycaemic control\n\nThe study does not involve any active involvement of the subjects and does not require any change from the standard medical management of the subjects. Each subject will be followed upon starting Glucophage XR therapy and until at least 12 weeks of treatment or discontinuation of treatment, whichever being earlier."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects diagnosed with type 2 diabetes in Asia Pacific region.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects diagnosed with type 2 diabetes\n* Subjects who have been given Glucophage XR for the treatment of the type 2 diabetes\n\nExclusion Criteria:\n\n* Subjects treated with Glucophage XR before the study initiation\n* Contraindicated use of Glucophage XR based on local label\n* Subjects who plan to continue on another oral anti diabetic therapy during the course of the study'}, 'identificationModule': {'nctId': 'NCT01117103', 'briefTitle': 'A Prospective, Observational Study to Assess and Evaluate the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Prospective, Observational Study on the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '200039-500'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mount Elizabeth', 'country': 'Singapore', 'facility': 'Kevin Tan Clinic For Diabetes, Thyroid & Hormones Pte Ltd'}], 'overallOfficials': [{'name': 'Dr Marcus Klein, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Pte. Ltd., Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Marcus Klein, Regional Medical Director', 'oldOrganization': 'Merck Pte. Ltd Singapore, an affiliate of Merk KGaA, Darmstadt, Germany'}}}}